Reading...
Play button
Play button
Use LEFT and RIGHT arrow keys to navigate between flashcards;
Use UP and DOWN arrow keys to flip the card;
H to show hint;
A reads text to speech;
94 Cards in this Set
- Front
- Back
|
• Pure Food and Drug Act
|
one of first laws to regulate food and drug, prohibited misbranding and adulterations, DID NOT REGULATE COSMETICS, NO INGREDIENTS, NO DIRECTIONS TO LIST.
|
|
|
• Food Drug and Cosmetic Act
|
new drugs must be proven SAFE, required DIRECTIONS, WARNINGS for additive medications, regulate cosmetics
|
|
|
• Durham
|
Humphrey Amendment
|
|
|
AAC
|
Actual Acquisition cost: The actual price a pharmacist pays when purchasing units of a drug product
|
|
|
ADE/ADR
|
Adverse drug experience/reaction
|
|
|
ANDA
|
Abbreviated New Drug Application: Requires only proof of bio equivalence and acceptable manufacturing practices
|
|
|
AWP
|
Average Wholesale price: publish wholesale price used to base RX drug pricing
|
|
|
DEA
|
Drug Enforcement Agency: Part of US department of justice, responsible for Federal Controlled Substances Act
|
|
|
DESI
|
Drug Efficacy Study Implementation: Drugs must be safe and effective, includes generics and innovator drugs
|
|
|
DHHS
|
Department of Health and Human Services: Includes FDA
|
|
|
DUR
|
Drug Utilization Review: review of drug use, prescribing patterns, and drug utilization. used to determine if drug are being prescribed and used properly
|
|
|
FDAMA
|
Food and Drug Administration Modernization Act. allow patients to not wait for NDA approval with life threatning or serious conditions.
|
|
|
FTC
|
Federal Trade Commission: Investigates unfair buisness practices
|
|
|
GMP
|
Good manufacturing Practices
|
|
|
HCFA
|
Health Care Financing Administration: Makes Medicare and Medicaid policies
|
|
|
HP/HPUS
|
Homeopathic Pharmacopeia of the US
|
|
|
JCAHO
|
Joint Commission on Accreditation Of Health Care Organizations
|
|
|
NDA
|
New Drug Application
|
|
|
NDC
|
National Drug Code: codes to identify specific drug products
|
|
|
PI
|
Package Insert: information provided with prescription medications
|
|
|
PPI
|
Patient Package Insert: Information is written in lay terms, Intended to educate patient about potential dangers and proper use, Required on First fill or first dose and every refill
|
|
|
PPPA
|
Poison Prevention Packaging Act: required on refills, iron>250 mg, APAP, ASA, Diphenhydramine>66 mg and others
|
|
|
PDUFA
|
Prescription Drug User Free Act
|
|
|
PTRA
|
Patent Term Restoration Act: codified FDA’s ANDA policy, concession for innovator drug manufacturers, bio equivalence could vary 20% either way, labeling must be same for generic.
|
|
|
Pure Food and Drug Act
|
one of first laws to regulate food and drug, prohibited misbranding and adulterations, DID NOT REGULATE COSMETICS, NO INGREDIENTS, NO DIRECTIONS TO LIST.
|
|
|
Food Drug and Cosmetic Act
|
new drugs must be proven SAFE, required DIRECTIONS, WARNINGS for additive medications, regulate cosmetics
|
|
|
Durham-Humphrey Amendment
|
established OTC AND PRESCRIPTION DRUGS (LEGEND), prescription NEEDED NO DIRECTIONS, REQUIRED “CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION”
|
|
|
Kefauver-Harris Amendment
|
resulted from thalomide tradegy, drugs must BE SAFE AND EFFECTIVE, put FDA in charge of drug regulation and FTC for OTC, REQUIRED informed consent for drug trials, adverse reaction reporting, GMP requirement.
|
|
|
Prescription Drug Marketing Act
|
wholesalers LICENSED by state, RX drugs CANNOT be RE IMPORTED, drug samples - cannot be sold, traded or purchased, specific storage, handling, and record keeping, BANNED resale of prescriptions bought by hospital and research facilities.
|
|
|
Drug Price Competition and Patent-Term Restoration Act
|
shortened approval time for generic drug manufacturers, given 5 year patent once approved by FDA
|
|
|
Orphan Drug Act
|
drugs used to treat rare disease (<200,000 people), cost for making was prohibited, provided tax and licensing incentives to drug companies who made them
|
|
|
FDA Modernization Act
|
allowed expedited NDA approvals, regulated compounding: overseen by state and exempt from GMP, required “CAUTION: RX ONLY”, eliminated requirment for “Warning - may be habit forming”
|
|
|
USP DI and what each volume provides
|
Volume 1 - Drug Information for health care professional
Volume 2 - Advice for the patient Volume 3 - Approved Drug Products with Therapeutic Equivalence Evaluations (information from Orange book |
|
|
Cosmetics
|
Something to be applied to the body for the purpose of cleaning, beautifying, promoting attractiveness, or altering appearance. DOES NOT INCLUDE SOAP
|
|
|
Device
|
Any instrument: recognized in the USP/NF, used for the diagnosis, cure, treatment or prevention of disease,intended to affect the structure or function of the body, but is not a food.
|
|
|
Drug
|
Anything that: recognized by USP, intended for diagnosis, cure, treatment, or prevention of disease, intended to affect the structure or function of the body, but is not a food, article used as a component in the any of the above but is not a DEVICE.
|
|
|
Food
|
Somethng used for food or drink in humans or animals, including CHEWING GUM, and any component of food or drink.
|
|
|
Know the different Parts of Medicare and what each one covers.
|
Part A - Hospitalization Insurance: medical supplies and rental of medical appliances.
Part B - Physician Services Part C - Medicare Advantage(alternative to B), choice of a managed care plan Part D - Prescription Drug Benefit |
|
|
Know what drugs are and are NOT covered by Medicare Part D.
|
Covered - Most drugs covered including OTC but sometimes restricted, plan uses drug tiers,
DUR, PA’s, generic substitution Not covered - Barbiturates, BDZ, Weight loss/gain, fertility drugs, Cosmetic/hair growth, Cough/Cold drugs, Vitamins and Minerals, outpatient drugs requiring testing or monitoring |
|
|
Know the penalties of Fraud and Abuse, know the examples of what is NOT allowed.
|
Penalties - Max fine of $25,000, 5 year imprisonment, or both, Expulsion from Medicare and
medicaid programs, civil penalties to HHS Examples - NO COUPONS ACCEPTED, FILLING A PARTIAL AND BILLING FOR WHOLE REFILL WITHOUT MAKING ARRANGEMENTS FOR PICKING UP THE REMAINDER |
|
|
Know the requirements for an NDA and the definition of a new drug
|
Definition - Newly discovered chemicals, established drug in a new dosage form, new
therapeutic claims, new dosage levels, for a different patient population. |
|
|
Requirements of an NDA
|
Full reports of investigations showing the drug safety and efficacy
The drug’s components and composition The methods, facilities, and controls used in the manufacturing, processing, and packaging the drug Samples of the drug and its components The proposed labeling of the drug |
|
|
Know the definitions for adulteration
|
Adulteration - Refers to composition of a product (examples below)
Product is filthy, putrid, or decomposed Prepared, packaged, or held under unsanitary conditions Made under conditions that violate GMP Contains an unapproved color additive Strength, purity, or quality of drug is lower than official standards Contains a drug not recognized in official compendia Contains a substitute for the active drug |
|
|
definitions for misbranding.
|
Misbranding - Refers to the labeling (examples below)
False or misleading labeling Missing name or location of manufacturer, packer, or distributor Missing word or statement required by law Does not include established name of active drug Does not have each active drug ingredient identified Missing quantity of container contents Offers the sale of a drug under the name of another drug Inadequate directions for use or lack of appropriate warnings Does not state “RX ONLY” if available by prescription only |
|
|
Know the requirements of a patient packet insert. (make pneumonic)
|
required for rx only drugs, has 13 sections;
Description of drug, Clinical pharmacology, Indications and usage, Contraindications Warnings, Precautions, Adverse Reactions Potential for abuse or dependence, Sx and Tx of overdose, Dosage and administration, Available dosage forms, Date of PI revision, Recommended or usual dosage |
|
|
to define “adequate directions for use”.
|
Sufficient information for the lay person to understand and safely use. Mandated by Durham
Humphrey Amendment - required for OTC and those dispensed and provided as “RX ONLY” |
|
|
define labeling.
|
Label - written, printed or graphic material
Labeling - information printed on the label or outside package, included labels Other definitions - All labels and other written, printed, or graphic matter either on the product, its container, its wrapper, or accompanying product Information printed by the pharmacist on the prescription label for a drug product being dispensed |
|
|
Know the labeling requirements for a manufacturer’s container.
|
Name and address, Established name of product, Net quantity, Weight of active ingredient in each dosage unit, Federal legend, Route of administration, Special storage directions, Manufacturer’s control (lot) number, Expiration date
|
|
|
Know which therapeutically inactive ingredients are NOT allowed in what drug product.
|
Colored agents not used in OPHTHALMIC OR PARENTERAL preparations.
|
|
|
Know the requirements for selling Ipecac syrup.
|
EMERGENCY USE ONLY, MUST CONTACT MD, ED OR PCC prior to use, DO NOT USE IN unconscious persons, sold in 1 OUNCE containers, keep out of reach of children
|
|
|
Know the features of the 2006 redesigned packet inserts.
|
Highlights: Boxed Warnings, Indications and Usage, Dosage and Administration
Table of Contents Date of initial product approval Toll-free number and Internet reporting information Patient Counseling Information |
|
|
Know the categories for Pregnancy Warnings.
|
Category A – no risk
Category B – no pregnancy risk in animal studies Category C – safety in human pregnancy not determined Category D – positive evidence of risk in humans Category X – risk outweighs benefits in animals and humans. Contraindicated in women of childbearing age. Drugs – Accutane, Cytotec, Thalidomide, most statins |
|
|
Be able to define Risk Management Programs.
|
Guidelines established by FDA for drug companies to follow for distribution of drugs with
special safety concerns. Some of the programs include (FYI), Thalidomide (STEPS Program) Isotretinoin (iPLEDGE) Clozaril National Registry Lotronex (PPL) Tracleer (TAP) Tikosyn (TIPS) Iressa (IRESSA Access Program) Nexavar (REACH) Convenient Access, Responsible Education (CARE) |
|
|
Know the guidelines for “Off-labeled Uses”.
|
Discouraged by FDA, but LEGAL if used in occasional patient. MFG may distribute peer
reviewed research that described off label use. Pharmacist can provide info but NOT RECOMMEND. |
|
|
Know the beyond-use dating criteria for repackaging unit dose drug products.
|
Repackaged into single use- Reuse considerations (States determine) and Expiration date changes
NOT to exceed 25% or remaining date between the date of repacking and the original date OR a 12 month dating from when the drug was repackaged, whichever or the two is LEAST |
|
|
Know when MedWatch and MedMARx reporting are used.
|
Know when MedWatch and MedMARx reporting are used.
MedWatch - ADE and medical product defect reporting MedMARx - Medication Errors These are voluntary and web based |
|
|
Know the classes of Drug Recall and to whom the responsibility falls.
|
Drug Recalls implemented by FDA. Classes (reasons for recall);
Class I – possible serious health consequence, Notify suppliers and patients Class II – may cause temporary or reversible effect, Notify suppliers Class III – unlikely to cause any problem Manufacturer sends recall notices, Pharmacist’s responsibility to be aware of all recalls Voluntary discontinuation, FDA considers “potentially dangerous” |
|
|
Know the components of the FDA Compliance Policy for Compounding.
|
\Beyond-use dating
Nonaqueous liquids and solids made using commercial products Not more than 25% of time remaining on the product or maximum of 6 months, whichever is less Aqueous solutions made from solids obtained from commercial products: 14 days stored at cold temperature All other products: duration of therapy, NOT more than 30 days |
|
|
Know the beyond-use dating criteria for compounded products.
|
Beyond-use dating
Nonaqueous liquids and solids made using commercial products Not more than 25% of time remaining on the product or maximum of 6 months, whichever is less Aqueous solutions made from solids obtained from commercial products: 14 days stored at cold temperature All other products: duration of therapy, NOT more than 30 days |
|
|
Know the difference between low-risk and high-risk sterile product compounding and be able to give an example of both.
|
Low-risk: closed system; transfer solution from a drug product with needle or syringe; TPN with commercial solutions.
High-risk: More complex to assure sterility and safety of final product Category I or II. I: Pooling sterile products for transfers; complex compounding; infusions for multiday use with pump. II: non-sterile substances; “open systems” morphine solution from powder; sterile nutritional products with non-sterile products. |
|
|
Know what is required for Drug Product Substitution.
|
Key issue is pharmaceutically equivalent
Same active ingredient, Same dosage form,Same route of administration, Identical strength or concentration, Excipients (non-active) ingredients may be different |
|
|
Know what the Orange Book is used for.
|
Approved Products with Therapeutic Equivalence Evaluations
Ratings: “A” products = bioequivalent and therapeutcially equivalent. “B” products = not bioequivalent An “A” product may be substituted for another “A” product, but never a “B” for an “A.” BUT, it must be the same dosage form |
|
|
Know the OBRA 90 requirements for patient information profiles.
|
Patient’s name, address, phone / Age or DOB /Sex / Allergies/ Disease state /Medications previously dispensed. /
Any pharmacists comments. |
|
|
Know what determines the scheduling of controlled substances.
|
They are scheduled based on abuse potential and safety profile
|
|
|
Be able to define an ultimate user.
|
A person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or by a member of his household.
|
|
|
Know what determines the validity of a prescription (due diligence and DEA#).
|
Only prescriptions for legitimate purpose are valid and determined by medical examination
Pharmacist is also held accountable for this provision Prescribers may dispense CSs, but must order from a supplier or manufacturer NOT via a prescription for office use Due diligence from the pharmacist to determine whether of not the prescription was filled or not - for duplicate prescriptions. |
|
|
Characteristics of a DEA
|
DEA Number
Individuals, manufacturers, distributors, laboratories, narcotic treatment programs, or dispensers must be registered with DEA Hospital registrations are issued to the entire hospital as an “Institutional practitioners” Registration expires 36 months from the initial registration period |
|
|
Know the specific DEA forms (222, 224, 225, etc).
|
DEA 222 - Purchasing and transfering C-1 and C-2’s.
DEA 222a - ordering more DEA 222 forms DEA 224 - Pharmacies DEA 225 - Manufacturers or researchers DEA 363 - Narcotic treatment programs |
|
|
Understand corresponding liability.
|
Prescriptions may be issued by an individual practitioner
Responsibility for proper prescribing rests with the practitioner, but corresponding responsibility rests with the pharmacists AMA prohibits physicians to treat themselves or family members unless its an emergency |
|
|
Be able to define a narcotic drug and be able to give examples.
|
Any drug that is derived or synthesised from opium, opiates and their derivatives and does not include the alkaloids of opium, poppy straw and concentrate, coca leaves except extracts from which cocaine, ecgonine and their derivatives, cocaine, ecgonine and their derivatives and salts and compounds containing any of these ingredients.
|
|
|
Know what classifies a drug as a Schedule I?
|
**Schedule I**
Have a high potential for abuse Have no currently acceptable medical use in the US Lack accepted information on the safety of its use Examples: Heroin, LSD, Marijuana, Gamma-Hydroxybutyric acid (GHB), Methaqualone, Mescaline |
|
|
Know what classifies a drug as a Schedule II. be able to give examples.
|
Have a high potential for abuse
Have currently acceptable medical use in the US or acceptable use with severe restrictions Abuse may lead to severe physical and psychological dependence Examples: Opiates and opioids, Cocaine, Codeine, Fentanyl, Hydromorphone, Meperidine, Methadone, Morphine, Oxycodone, Stimulants, Amphetamine, Methylphenidate, Methamphetamine, Depressants (pentobarbital, secobarbital) and Hallucinogens (phencyclidine (PCP) |
|
|
Know what classifies a drug as a Schedule III controlled substance and be able to give examples.
|
Have a potential for abuse less than Schedule I or Schedule II
Have currently acceptable uses in the US Abuse may lead to moderate or low physical dependence or high psychological dependence Examples: Tylenol w/ Codeine, Anabolic Steroids, Buprenorphine and Buprenorphine/ Naloxone, Butalbital, Barbiturates combined with noncontrolled drugs or as a suppository, Narcotic drugs in limited quantities, Products are evenly divisible by (3) such as 1.8 grams of codeine per 100mL or not more than 90 mg per dosage unit |
|
|
Know what classifies a drug as a Schedule IV controlled substance and be able to give examples.
|
Have a low potential for abuse relative to Schedule III
Have currently acceptable uses in the US Abuse may lead to limited physical or psychological dependence related to Schedule III drugs Examples: Sedatives hypnotics (alprazolam, chlordiazepoxide, flurazepam, oxazepam, temazepam, triazolam, zolpidem, clonazepam, diazepam, eszopiclone, zaleplon, midazolam) and Phenobarbital, Butorphanol, meprobamate, diethylpropion, sibutramine, propoxyphene |
|
|
Know what classifies a drug as a Schedule V controlled substance and be able to give examples.
|
Have a low potential for abuse relative to Schedule IV
Have currently acceptable medical use in the US Abuse may lead to limited physical or psychological dependence relative to schedule IV drugs Examples:Narcotic drugs containing non-narcotic active ingredients, Products are evenly divisible by (5) such as 200 mg of codeine per 100 mL or per 100 grams **Exempt substances** --- Librax (Tabs and Caps)- chlordiazepoxide, Pyridium Plus Tabs- butabarbital, Donnatal (Tabs and Caps)- phenobarbital, Annaspaz PB- phenobarbital |
|
|
Know the requirements of a controlled substances in general
|
Controlled substances:
Signed and dated on day written Full name and address of patient Drug name, strength, and dosage form Quantity and directions for use The name, address, and DEA number of the prescriber (or hospital) Signature of prescriber – indelible (not erasable) Agent can prepare the Rx, but prescriber still must sign (legal document signature) Note: Individual practitioners exempted from registration MUST use hospital DEA number and their special internal code |
|
|
Know the requirements of a Schedule II controlled substance prescription.
|
Written Rxs and Drug Orders
Pharmacists may fill and dispense Individual practitioner may administer or dispense directly in the course of their professional practice w/o a prescription An institutional pharmacist or other healthcare practitioner may administer or dispense (but NOT prescribe) |
|
|
Know what can be changed or corrected on a Schedule II controlled substance prescription.
|
Address, drug strength/quantity, and directions for use
|
|
|
Know the labeling requirements for controlled substance commercial containers.
|
Date of filling
Pharmacy name and address Serial number of Rx Patient name Prescriber name Directions for use “Caution” statement Does not apply to hospital patients |
|
|
Know the specifics of the DEA 222 form; how to order,
|
Order
Purchaser must complete the form Copy 1 (Brown) and 2 (Green) is submitted to supplier for order placement, Copy 3 (Blue) is retained Orders that cannot be filled may be partially filled but balance MUST be supplied within 60 days Supplier retains Copy 1 and forwards Copy 2 to DEA and The supplier is the “filler” |
|
|
DEA 22 form: how to transfer, purchase;
|
Purchase or transferred using DEA 222 form
Purchase, transfer of schedule I or II products Order forms obtained by registrant only (Power of Attorney) Order form may be completed by registrant only Issued by mail and contain 7 or 14 forms Comes in triplicate form Additional forms available by contacting DEA Form may not be altered or changed |
|
|
DEA 22 form: Completion
|
Must be executed by registrant
Must be prepared by typewriter, computer printer, pen, or indelible pencil Must copy/print through to the 3rd copy of the triplicate Only one item (drug product) per line The number of lines completed must be noted at the bottom of the form Name and address of supplier |
|
|
DEA 22 form: Filling
|
ONLY those registered manufacturer or distributor
Exceptions Pharmacist discontinuing a pharmacy Registrant’s registration expiring and not re-registering Registrant returning controlled substance to the supplier (wholesaler or manufacturer) Registered compounder of narcotic substances for use off-site in a narcotic treatment program Note: Schedule I or II drugs can be transferred from one registrant to another (i.e. pharmacy to pharmacy) |
|
|
DEA 22 form: Lost or Stolen, Storage
|
Lost or stolen Order Forms – report to the DEA asap. Storage of Forms - 2 years
|
|
|
Specific DEA Forms
|
DEA 222 - Purchasing and transfering C-1 and C-2’s.
DEA 222a - ordering more DEA 222 forms DEA 224 - Pharmacies DEA 225 - Manufacturers or researchers DEA 363 - Narcotic treatment programs |
|
|
Be able to define a Power of Attorney.
|
Licensed registrant to prepare/sign DEA 222 form. This is done by the use of a power of attorney form signed by the primary authorized person. This form must be available to inspectors and valid until revoked by applicant. A backup is a good idea
|
|
|
Know what happens if the supplier is unable to supply the requested Schedule II controlled substances
|
Partial filling is permissible when:
Unable to supply the full quantity in a written or emergency situation Notation made on the quantity supplied on the Rx face Remaining portion must be filled within 72 hours. If not filled within 72 hours, RPh must contact the prescriber, no further quantity can be supplied without a new Rx Can NOT be done at the patient’s request, but only done when the RPh is unable Partial Filling in LTC Can be done for LTC or terminally ill pts. Must write on the Rx back “LTC” or “terminally ill” Record on Rx back – date, quantity dispensed, remaining amount authorized, and identification of dispensing RPh Total partial fills quantity can not exceed the total quantity prescribed Valid for a period of < or = 60 days |
|
|
Know the benefits of using CSOS.
|
Electronic system to order C I to C V drugs
No line item limit (Form 222 has ten lines) Faster transactions for smaller inventories Decreased number of ordering errors and cost Copy submitted to DEA Individual purchaser is required to acquire a CSOS digital certificate Purchaser requirements – sign on the electronic order and complete all data fields |
|
|
Know what knowingly means in reference to dispensing a controlled substance.
|
Knowingly filling a prescription that is NOT for a legitimate purpose is a Federal violation
|
|
|
if controlled substances can be prescribed for “office use”.
|
Prescribers may dispense CSs, but must order from a supplier or manufacturer NOT via a prescription for office use
A pharmacist may compound for “office use” Aqueous, oleaginous (oily/greasy) or solid dosage form Contains < 20% controlled substance Distributed only to the practitioner |
|
|
Know if controlled substances can be prescribed for self use or for family members.
|
AMA prohibits physicians to treat themselves or family members unless its an emergency.
Pharmacist has legal responsibility to use sound judgment |
|
|
Know the proper usage of an institutions DEA#.
|
Individual practitioners exempted from registration MUST use hospital DEA number and their special internal code
|
|
|
Know the guidelines for accepting an emergency request for a Schedule II controlled substance
|
An emergency request is:
Immediate use for proper treatment No appropriate treatment is available Not reasonably possible for prescriber to provide a written Rx |
|
|
Know the guidelines for dispensing an emergency request for a Schedule II controlled substance
|
RPh can dispense provided that the quantity be limited to only an emergency period
Must be immediately reduce to writing RPh must make a reasonable effort to determine if the order is legitimate The prescriber MUST send the pharmacist a written order within 7 days “Cover” Rx written on its face “ Authorization for Emergency Dispensing” and the date of oral order RPh must notify the DEA if “cover” Rx is not received within that time frame |
